Item 7.01 Regulation FD Disclosure
On
The information in this Item 7.01, including Exhibit 99.1 to this Current Report on Form 8-K, the presentation referenced above and the other content on our website, shall not be deemed "filed" for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, except as expressly set forth by specific reference in such a filing.
Item 8.01 Other Events
On
GreenLight has advanced its portfolio strategy, target product profiles and delivery capabilities in a number of ways it will discuss as part of the R&D day. GreenLight intends to use, and has taken steps to use, its platform to expand its market access by progressing its product development from generation 1, high-value crops (e.g. single target solutions designed to demonstrate proof-of-concept for dsRNA-based agricultural solutions intended to be primarily registered and commercialized by GreenLight), to generation 2, multitarget products (e.g. solutions designed to address multiple targets, anticipated to be developed in collaboration with partners that possess significant distribution capabilities for large markets and retained in house for high value), to generation 3, systemic delivery capabilities (e.g. solutions delivered to the plant to target weeds, nematodes or improve nutrition; intended primarily to be developed in partnership with crop fertility and other potential partners).
Progress updates in GreenLight's plant health pipeline are as follows:
Generation 1: High-Value Crops
CalanthaTM: Subject to receiving regulatory approval and applicable state
registrations in the US, we anticipate and are in active preparations for
commercial launch prior to the end of 2023. As part of this effort, we are in
active discussions with territory-relevant distributors across the US as
potential partners to support our planned commercial launch. Furthermore, we are
planning to submit CalanthaTM for regulatory approval in the EU,
Varroa mite solution: In
Generation 2: Multitarget Solutions
GreenLight is expanding certain dsRNA-based fungal, insecticide, and acaricide programs into solutions that are designed to address multiple targets.
Powdery Mildew ("PM"): A complex of diseases that impacts a wide range of crops and plants consisting of multiple species that are slightly genetically diverse. GreenLight has further developed its powdery mildew solution by modifying our lead sequence to enable potential control of multiple targets (i.e. cucurbits PM, cereal PM, and ornamentals PM in addition to original target of vine PM). Our field trials have demonstrated that sprayed unformulated (naked) dsRNA decreases disease severity in grapes and performed similarly to the biological standard in field trials. In a similar field trial on zucchini, data showed that our naked dsRNA sequences performed well but inferior to field trial standards. However, when formulated with adjuvants, our trial results showed that our formulated dsRNA provided a larger reduction in disease severity compared to the industry standard. We are targeting our first regulatory submission of our powdery mildew program in 2024 in the US.
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Generation 3: Systemic Delivery
Through data from field trial studies conducted at the end of 2022, GreenLight
has demonstrated stability of RNA through a standard seed treatment process and
dsRNA delivery into plants, showing decreased fusarium disease severity in
lettuce seed treatment field trials across two locations and three lettuce
varieties. Additionally, data from early experiments (n+2) conducted in
Forward-Looking Statements
Certain statements in this Current Report on Form 8-K may constitute
"forward-looking statements" for purposes of the federal securities laws. Our
forward-looking statements include, but are not limited to, statements regarding
our or our management team's expectations, hopes, beliefs, intentions or
strategies regarding the future, including those relating to the success, cost
and timing of our research and development activities in our plant and human
health programs, the timing of regulatory submissions and approvals, our ability
to commercialize our products, the acceptance of RNA-based technologies by
regulators and the public, our ability to raise and productively deploy capital
and the rate at which we can successfully bring products to market, our
projected cash runway and our ability to obtain funding for our operations when
needed. Forward-looking statements include statements relating to our management
team's expectations, hopes, beliefs, intentions or strategies regarding the
future. In addition, any statements that refer to projections, forecasts or
other characterizations of future events or circumstances, including any
underlying assumptions, are forward-looking statements. The words "anticipate,"
"believe," "contemplate," "continue," "could," "estimate," "expect," "intends,"
"may," "might," "plan," "possible," "potential," "predict," "project," "should,"
"will," "would" and similar expressions may identify forward-looking statements,
but the absence of these words does not mean that a statement is not
forward-looking. These forward-looking statements are based on current
expectations and beliefs concerning future developments and their potential
effects. There can be no assurance that future developments affecting us will be
those that we have anticipated. These forward-looking statements involve a
number of risks, uncertainties (some of which are beyond our control) or other
assumptions that may cause actual results or performance to be materially
different from those expressed or implied by these forward-looking statements.
These risks and uncertainties include, but are not limited to, those factors
described under the heading "Risk Factors" in the Company's most recent Annual
Report on Form 10-K filed with the
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Item 9.01 Financial Statements and Exhibits
(d) Exhibits
Exhibit No. Description
99.1 Press Release issued by
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